Public access CPR and AED device

ABSTRACT

A system for resuscitation of a heart attack victim. The system includes CPR device which compresses the victim&#39;s chest, a defibrillator which may be used to defibrillate the patient, and an identification system for identifying the person operating the system. Depending on the identity of the operator, the system permits varying degrees of access to components and enablement of the functions of the various subsystems.

This application is a continuation of U.S. application Ser. No.09/263,656 filed Mar. 5, 1999, now U.S. Pat. No. 6,398,744.

FIELD OF THE INVENTION

This invention relates to the resuscitation of cardiac arrest victims.

BACKGROUND OF THE INVENTION

Cardiopulmonary resuscitation (CPR) is a well known and valuable methodof first aid. CPR is used to resuscitate people who have suffered fromcardiac arrest after heart attack, electric shock, chest injury and manyother causes. During cardiac arrest, the heart stops pumping blood, anda person suffering cardiac arrest will soon suffer brain damage fromlack of blood supply to the brain. Thus, CPR requires repetitive chestcompression to squeeze the heart and the thoracic cavity to pump bloodthrough the body. Very often, the victim is not breathing, and mouth tomouth artificial respiration or a bag valve mask is used to supply airto the lungs while the chest compression pumps blood through the body.The methods of providing oxygenated airflow to the lungs are referred toas ventilation.

It has been widely noted that CPR and chest compression can save cardiacarrest victims, especially when applied immediately after cardiacarrest. Chest compression requires that the person providing chestcompression repetitively push down on the sternum of the victim at80-100 compressions per minute. CPR and closed chest compression can beused anywhere, wherever the cardiac arrest victim is stricken. In thefield, away from the hospital, CPR may be accomplished by ill-trainedby-standers or highly trained paramedics and ambulance personnel.

When a first aid provider performs chest compression well, blood flow inthe body is typically about 25-30% of normal blood flow. This is enoughblood flow to prevent brain damage. However, when chest compression isrequired for long periods of time, it is difficult if not impossible tomaintain adequate compression of the heart and rib cage. Evenexperienced paramedics cannot maintain adequate chest compression formore than a few minutes. Hightower, et al., Decay In Quality Of ChestCompressions Over Time, 26 Ann. Emerg. Med. 300 (September 1995). Thus,long periods of CPR, when required, are not often successful atsustaining or reviving the victim. At the same time, it appears that, ifchest compression could be adequately maintained, cardiac arrest victimscould be sustained for extended periods of time. Occasional reports ofextended CPR efforts (45-90 minutes) have been reported, with thevictims eventually being saved by coronary bypass surgery. See Tovar, etal., Successful Myocardial Revascularization and Neurologic Recovery, 22Texas Heart J. 271 (1995).

In efforts to provide better blood flow and increase the effectivenessof bystander resuscitation efforts, chest compression devices capable ofperforming the tasks of the basic CPR procedure have been proposed andused. Our own modular CPR device, described in our U.S. Pat. Nos.6,142,962 and 6,066,106, provide for circumferential chest compressionperformed by a battery operated motor and clutch assembly. The chestcompressions are accomplished automatically after installation andinitialization of the system. The devices are designed for use by bothuntrained and trained operators, so that they may be used on patients asquickly as possible. It is intended that any bystander recognizing afallen patient will be able to gain access to a nearby device, installthe device, and initiate the operation the device to commence chestcompression and patient monitoring.

Our CPR devices described in our U.S. Pat. Nos. 6,142,962 and 6,066,106also incorporate an automatic emergency defibrillator. Defibrillation isa well known technique for restoring normal heart rhythm to a patientwho is in cardiac arrest due to ventricular fibrillation or ventriculartachycardia. It involves attaching electrodes to the patient andapplying a large electrical shock to the patient. Defibrillation canresuscitate a large class of cardiac arrest patients, and its success isenhanced by application of the shock early in the resuscitation effort.A minute or so of chest compression also enhances the effectiveness ofdefibrillation shocks in reviving the patient.

Recently, automatic emergency defibrillators (AED) have been installedin controlled areas such as airplanes, where the presence of trainedoperators and secure access to the AED can be maintained. The practiceof installing AED's in controlled areas is sometimes referred to asPublic Access Defibrillation. However, laws in most jurisdictions forbidinstallation of the devices without maintenance of a number of trainedoperators in the controlled area and oversight of the programmaintenance by a doctor.

Our U.S. Pat. No. 6,213,960 provides a control system for operating anautomatic defibrillator and an automatic chest compression device incoordination with each other to enhance the effectiveness of theresuscitation. The device also provides electro-stimulation forelectroventilation, electro-counterpulsion, abdominal binding andglottic closure, all coordinated with the chest compression device toeffect electro-stimulation at various points in the compression cycle.

SUMMARY

The public access CPR and AED device described below is intended to beinstalled in public areas where access is readily available tobystanders, first responders, EMT's and doctors. However, it is notnecessary, nor desirable, to permit full access of the device to theentire range of people who might desire or require access since someusers will not be properly trained to supervise the device's operation.To control and thus permit the optimal degree of access to the system, atiered access system is used to control physical access and functionalenablement of the system. Physical access means access to the deviceitself, and/or access to certain accessories used for patient treatmentin conjunction with the device that may be stored in the device or withthe device (ET tubes, venous access kits, laryngoscopes, drugs, etc.).Functional enablement refers to the system allowing operation of certainfunctions, such as chest compression, alteration of setpoints,application of defibrillating shock, etc. Thus, the system must be told(or determine for itself) that it is permitted to initiate a therapeuticmode before it does so. One mechanism for differentiating the type ofuser accessing the device is through the identification subsystemsensors, since, for example, only trained personnel are “key holders”(as described in further detail below in reference to FIG. 2.)

The intended models of use for these systems include installation inhospitals and ambulances, and widespread installation in public areassuch as workplaces, shopping centers, athletic facilities and stadiums,and even in homes of patients with an identified high risk of cardiacarrest. The devices may be installed in hospitals and ambulances withoutconcern about the level of training for the expected user, because theexpected user will be a highly trained operator such as a physician,nurse or emergency medical technician. These trained users can beexpected or required to have the expertise necessary to supervise andadminister all phases of the resuscitation protocol. However, becauseinstallation and activation within minutes of the onset of cardiacarrest is critical to saving a patient's life, it is desirable to allowthe device to be deployed by untrained bystanders or minimally trainedfirst responders, and permit trained first responders and untrainedbystanders to operate the device in safe modes. The system reservesphysical access to advanced equipment and/or functional enablement ofadvanced modes which may present some danger to the patient for trainedfirst responders. The system may have additional treatment modules, suchas drug delivery equipment, that should only be used by expertoperators, and the system prohibits access to these modules to all butidentified expert operators. Trained first responders and expertoperators may identify themselves to the system through the use ofaccess cards, identification numbers or access codes, while the systemmay assume lack of identification indicates use by an untrainedbystander. In all instances of use, the system initiates communicationswith a remote medical center, where operator identity may be confirmedand the level of access and enablement of the system may be adjustedremotely.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is diagram of a chest compression, ventilation and defibrillationdevice controlled by the tiered access system.

FIG. 2 is a block diagram of the system for controlling access to aresuscitation device.

FIGS. 3A and 3B show the system flow chart for system of FIG. 2, withdetails of the tiered access system.

FIG. 4 shows the device of FIG. 1 installed in a locked mounting device.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows the Public Access CPR and AED Device mounted on a patient 1and ready for use. The chest compression subsystem 2 comprises the motorbox 3, the belt cartridge 4, and the compression belt 5 with left andright portions 5L and 5R. The belt is fastened around the patient withfasteners 6 (which may be buckles, Velcro™ hook and loop fasteners orother fasteners with sensors to sense when the belt is fastened).Ventilation electrodes 7L and 7R are mounted on the belts in the area ofthe lower chest and placed bilaterally over the diaphragm. Bipolarelectrodes 8L and 8R (or electrode pairs) may also be placed on theneck, bilaterally, to stimulate the phrenic nerve which coursesdownwardly through the neck. Defibrillation electrodes 9R and 9L areplaced on the right and left sides of the chest and they may also belocated below the patient, on the spine between the shoulder blades, andon the center of the chest, respectively. These electrodes are used forestablishing the electrical contact needed for EKG sensing, and also fordefibrillating the patient. Counterpulsion electrodes 10 i and 10 s areplaced on the skin over the abdominal or rectus muscles, with a line ofpositive electrodes placed in the superior position and a line of groundelectrodes placed in the inferior position. Glottic control electrodesare disposed on an electrode patch 11 placed on the neck along thetracheoesophageal groove.

The control box 12 houses a computer system that controls the variousfunctions of the device. The computer system controls operation of thechest compression device, acquisition of signals from various feedbackmechanisms such as the EKG electrodes, and application of stimulating ordefibrillation pulses to the electrodes. (Commercially availablesensors, electrodes and EKG analysis systems such as the ForeRunner™ AEDsold by HP Heartstream can be used as the basis for the cardiovertingsubsystem). The computer system may also control operation of additionaltherapeutic modules, such as drug injection modules. The computer systemalso controls the communications subsystem 13 used to initiate andmaintain communication with a remote medical facility. Thecommunications subsystem may include a telephone handset, keypad anddisplay.

An identification subsystem 14 is operably connected to the control box12 and/or communication subsystem, 13 and may include a key card reader15 for reading an encoded card, a keyboard or touchpad 16 for entry ofan access code or personal identification number, and a biometric sensor17 for reading a biometric parameter of the user such as a fingerprint.A secure device enclosure 18 is connected to the control box throughelectronic cable 19, and is locked or unlocked as controlled by thecomputer system. The secure device enclosure may house ventilationequipment such as bag valve masks or ventilation tubes, medication usedin the ACLS protocol, invasive devices such as intravenous needles (and,if desired, defibrillation electrodes). The system also includesdiagnostic devices for sensing EKG, pulse, respiration and temperature.Thus, the system includes several means for resuscitation of the patientand several means for sensing biological parameters of the patient todiagnose the patient. Any number of medical devices, includingresuscitation devices and diagnostic devices, may be employed in thesystem.

The Public Access CPR and AED Device illustrated in FIG. 1 compressesthe chest to force blood circulation; stimulates the patient's nerves tocause an inhaling contraction of the diaphragm, the intercostal muscles,and the abdominal muscles; stimulates the patient's abdominal muscles tocause binding or counterpulsile contraction of the abdomen; and deliversdefibrillating electrical shock to the patient. The computer systemcontrols all of these therapeutic modes, subject to initialization andenablement of these actions by the operator or remote medical center.

The device is intended to be installed in public areas where access isreadily available to bystanders, first responders, EMT's and doctors.The device should be quickly installed on a heart attack victim, priorto the arrival of specially trained users. However, it is not necessary,nor desirable, to permit full access of the device to the entire rangeof people who might desire or require access since some users will notbe properly trained to supervise the device's operation. To control andthus permit the optimal degree of access to the system, a tiered accesssystem is used to control physical access and functional enablement ofthe system.

Physical access means access to the device itself, and/or access tocertain accessories used for patient treatment in conjunction with thedevice that may be stored in the device or with the device (ET tubes,venous access kits, laryngoscopes, drugs, etc.). Functional enablementrefers to the system allowing operation of certain functions, such aschest compression, alteration of setpoints, application ofdefibrillating shock, etc. The system must be told (or determine foritself) that it is permitted to initiate a therapeutic mode before itdoes so. One mechanism for differentiating the type of user accessingthe device is through the identification subsystem sensors, since, forexample, only trained personnel are “key holders” (as described infurther detail below in reference to FIG. 3.)

The system utilizes a remote medical facility (not shown). The medicalfacility may maintain a database that stores user identificationinformation, an indication of the user's permitted level of access, andthe user's authentication information.

FIG. 2 illustrates the overall system functions. The initializationmodule 20 waits for user input that indicates the system is in use andmust begin operation. Once the device is accessed, the initializationmodule operates to start several modules. The system establishescommunications with a remote medical facility through the communicationsmodule 21. During use, the system will accept user identificationinformation, as indicated by the user identification input module 22.The system analyzes the user's identification, input from a remotemedical facility if available, in the identification processing module23. The system utilizes the user's identity to determine whether or nota user will be allowed physical access to the device, as indicated bythe physical access module 24. The system also uses the user's identityto determine which of the various capabilities of the system will beenabled, as indicated by the functional enablement module 25. The remoteinput module 26 receives input from a remote medical facility, and thisinput can be used to control the resuscitation devices.

FIGS. 3A and 3B show the system flow chart for system of FIG. 2, withdetails of the tiered access system. The initialization module 20achieves the system's ready state. The device is intended to be storedfor extended periods of time before it is used, thus making itimpractical to keep the computerized components fully operational at alltimes and the system in constant communication with a remote medicalfacility. Thus, whenever the system is used, it must be started up sothat the various subsystems can achieve a ready state. The system can bedesigned to start up as any computerized system, either from acompletely un-powered condition or from a sleep mode, in which thecomputer control module is always energized to the extent necessary tosense an input (comparable to a lap-top computer in sleep mode).

The initialization module monitors the system housing to sense a unitaccess attempt. This is also known as an initiating event, such as theremoval of the device from a storage location, disconnection from acharging battery holder, insertion of a key card into the card reader,or operation of any startup sequence initiated by the operator (pushinga button, entering an access code, etc). FIGS. 3A and 3B illustrates anembodiment of the system which uses insertion of a key card (for trainedusers) as one initiating event, and a push button or telephone pick up(for bystanders) as an alternate initiating event.

Upon recognition of the initiating event, in addition to the steps takenin the CPR protocol as illustrated in our prior patents, theinitialization module establishes a communication link with a remotemedical facility. Via this link, the initialization module communicatesthe activation attempt to the medical facility, and differentiates tothe medical facility the type of initiating event (physical removal ofthe device versus insertion of a key card). In this way, the medicalfacility is made aware of the device activation as well as the type ofuser activating the device.

The initialization module also communicates an encrypted device ID tothe remote medical facility such that the remote medical facility willknow where to send trained EMTs. The initialization module alsooptionally activates an associated video camera system.

The user identification module 22 seeks input from the identificationsubsystem 14. The identification subsystem may include a key card reader15, an access code system (touchpad) 16, or mechanical key system (notshown). In this manner, operators of different training levels may beissued a key card, security code, or actual key, so that these trainedoperators can identify themselves to the system as “key holders”.Several levels of access may be provided by use of several “keys,” eachissued to different levels of trained users and each accepted by thesystem as identification of a different level of trained user. Thisprovides for the “tiered” access system.

The identification subsystem 14 may also include an optional biometricsensor 17 for use in coordination with a key card reader, using both thebiometric information on the key card and the sensed biometricinformation to ensure the user's identity, and using the traininginformation on the key card to determine the appropriate access to thedevice.

The identification subsystem 14 is mounted on the resuscitation device,and while the resuscitation device is mounted in the wall mount, it isalso detachably wired to the wall mount (through releasablecommunications cables and connectors) so that it can communicate withany electronic or communications equipment housed within the wall mount.The identification subsystem is thereby carried with the resuscitationdevice after the system has permitted the device to be detached from thewall mount.

The user identification module monitors the system waiting to sense aninput from the identification subsystem 14. If the user identificationmodule senses a key card, access code, or mechanical key, the modulereads, for example, the key card identification and communicates to theremote medical facility this information for the next step ofdetermining the physical access level attainable.

If the user identification module does not sense a key card, accesscode, mechanical key, or if for some reason the local identificationfails, redundancy and backup of the identification system is providedsuch that the user is interrogated by the remote medical facility toensure that the device is intended to be used for a cardiac arrestvictim. This may be necessary when a trained first responder or expertuser is available to supervise and operate the device, but cannot beidentified by the device due to loss of an access card or failure of theidentification devices. If local identification fails, thecommunications subsystem 13 (not shown) may be used to communicate theidentification information or backup identification information to theremote medical facility, and access can be granted by remote input intothe identification module. The backup information may be personalidentifying numbers of the operator, such as a unique access code or asocial security number. Thus the user identification module, uponfailure of identification, will respond to an access control signal fromthe remote medical facility. If the interrogation fails to confirmproper use, the device remains locked so that it remains available foran actual emergency. The system is reset and self check performed inanticipation of an actual emergency.

A concern with such a device is that it might be used by unauthorizedusers wrongfully in possession of a key. To avoid this possibility, thesystem can require redundant identification information, which can beprovided through biometric sensors. Trained users are issued a magneticstrip card which stores the users training level and access level, alongwith additional authenticating information. At the very least, theauthenticating information may be a personal identification number orPIN, which a user may enter through the keyboard after inserting theaccess card into the card reader. However, since some trained users maynot use the system often enough to ensure that they will remember a PIN,a biometric sensor such as a fingerprint reader may be used. Trainedusers are issued a key comprising an access card capable of storingbiometric information such as the user's fingerprint (retinal scaninformation, voice print, or other biometric data can be used). Thepurpose of the biometric data is to provide authentication withinformation that is guaranteed to be readily available to the user, andcannot be forgotten or lost. The access card may be a credit card sizedcard with a magnetic strip which contains the users identification, anindication of the users training level, and a representation of theusers fingerprint, or unique fingerprint information. These access cardsare then used in conjunction with an identification module whichincludes a card reader and determines the card users training level andrecorded fingerprint information, and also includes a fingerprint readerwhich reads the users fingerprint and compares it with the recordedfingerprint information to ensure that the user is actually the traineduser previously identified by a system oversight facility. The systemoversight facility can issue the access cards after training the users,thereby maintaining control of the training and the access card. Usingthis system, there is no need for communication with the systemoversight facility, and no need to refer to an extensive database ofuser identification information or biometric information, so that thematerial requirements for the identification module are eased. Biometricsensors which read and verify card-stored fingerprints are commerciallyavailable.

As illustrated in FIG. 3A, the user identification module 22 refers tothe physical access module 24 after the identification process has beencompleted. If the user is identified as a Level 1 bystander or Level 2first responder, the physical access module 24 permits access to thedevice such that it allows the device to be removed from the wall mount(through operation of relay operated locks or other electro-mechanicallocking devices). The device may then be installed on the patient by thebystander. If the user is identified as a level 3 expert operator orEMT, the physical access module may permit access to additionalcomponents, such as ACLS supplies (needles/IV/ET tubes) stored withinthe device or in the wall mount system (again, through operation ofelectro-mechanical locks such as electrically operated latches). If theuser is identified as a level 4 paramedic or doctor, the physical accessmodule may permit access to drugs. If the user is identified as a level0 maintenance technician, the system may permit access to the internalworkings of the device, such as mechanical components and computersystems to permit service access.

In a large portion of the expected uses, the resuscitation system willbe removed from the wall mount by a first operator, typically abystander. Shortly thereafter, EMT's should arrive on scene. While it isadvantageous to the patient to be fitted with the resuscitation deviceand sensing devices immediately, with the assistance of any availableperson, it is not necessarily advantageous to permit the system tooperate treatment devices which apply power to the body until moreexperienced operators such as EMT's arrive on scene. Thus, the useridentification module is designed so that operators arriving on sceneafter deployment of the system can enter their identificationinformation, and the system will functionally enable power emittingmedical devices and permit physical access to advanced equipment. WhenEMT's do arrive, communications with a remote medical facility shouldalready be established by the system through the initialization module.The EMT can enter his identification information, which can be processedby the onboard operating system or by the remote medical facility, andeither the onboard operating system or the remote medical facility canfunctionally enable power applying devices. The system may be redundantin its enablement capabilities, allowing enablement by either the remotemedical facility or by the local operator (of appropriate level), sothat enablement in proper situations is ensured by one or the other(i.e., in case of a communications failure with the remote medicalfacility).

The physical access module also provides for redundancy and backupwhere, after the EMT, paramedic, or doctor have arrived on the sceneafter an initial bystander access, the module monitors the device tosense a key card reader insertion or other access such that the nextlevel of care may be achieved. Essentially, the physical access moduleis in constant contact with the user identification module to performthis system update.

After the physical access module completes its task (or in parallel tothe operation of the physical access module), the system refers to thefunctional enablement module 25 illustrated in FIG. 3B. This moduleenables different parts of the control system depending on the accesslevel indicated by the identification module. We have illustrated in theflow chart an initial assignment of functional access which may changeaccording to experience, medical indications and legal requirements atthe time the device is used.

Where the user is identified as a level 1 bystander, indicating anuntrained user, the system will permit deployment of the device and useof the communications and sensing modules. For example, the system willallow the entire device to be removed from a storage base into which itis normally locked when not in use so that it may be transported to apatient. The system will not allow compression, defibrillation,electro-stimulation, access to stored medication, etc. when the user isidentified as a level 1 bystander. This is represented by Level 1 inFIG. 3B.

Where the user is identified as a level 2 trained first responder, thesystem will permit use of the communications modules, sensing modules,compression modules and electro-stimulation modules. The system permitsall the actions of the level 1 (bystander level), and additionallyenables compression. This is identified as Level 2 in FIG. 3B.Compression may be enabled in an automatic mode, meaning that itcommences as soon as proper installation of the compression belt isverified by the system, or it may be enabled such that compressioncommences when the user directs the system to commence compression withuser input from the keypad.

Where the user is identifies as a level 3 expert operator or EMT, allthe previous modules will be enabled and other more sensitive modulessuch as the defibrillation module may be enabled, and sensitive adjunctssuch as the drug injection devices and invasive sensing devices may beunlocked or enabled. The precise allocation of therapeutic modules todifferent access levels may vary as experience with the device indicatesthat therapeutic modules require more or less stringent controls. Thisis labeled as Level 3 in FIG. 3B.

Finally, where the user is identified as a doctor, the system enablesall therapeutic modes (such as ACLS drug delivery, pacing, etc.), andallows the doctor to adjust system thresholds and parameters (such asmaximum chest compression, compression rate, defibrillation power, etc.)This is labeled as Level 4 in the flow chart.

All levels provide for a dispatch of appropriate emergency personnel.All levels provide a communication, instruct and monitor deploymentfunction. All levels provide for monitoring and transmitting ofphysiological parameters (heartbeat, EKG, blood pressure, etc) to theremote medical facility. Finally, all levels provide communicationmodules so that the system may transmit the physiological data to theremote medical facility. It should be appreciated that the assignment ofphysical access and functional enablement levels to the differentclasses of users may vary considerably, and that therapeutic devices maybe added to the system in addition to the devices used to illustrate theinvention. For example, we expect that operation of the chestcompression device will prove to have little adverse effect if appliedto a patient who is not suffering from cardiac arrest, so thatapplication of chest compression may be permitted when the device isused by a level 1 bystander.

The remote input module allows the remote medical facility to remain inthe loop and control the operation in the field. The remote medicalfacility receives data via the functional access module. The remotefacility may then analyze the data and send remote control communicationto the field. For example, the remote medical facility may transmitsignals via the feedback module to the device to enable chestcompression or other features, as medically indicated by the sensedbiological parameters provided by the functional access module.

FIG. 4 shows the resuscitation device configured in a wall mount. Theresuscitation device is mounted and locked into a base 27 which isinstalled in an accessible place where it is likely to be needed, suchas in a shopping mall, workplace, theater or stadium. The wall mountedbase preferably has a charger for continuously charging the batteriesrequired by the resuscitation system and telephone connections if thesystem is to be implemented through cordless telephone communicationbetween the device and the remote medical facility (with the cordlesstelephone base incorporated into the base). The motor box 3,communications module 13, identification module 14 rest in the base, andare locked in the base when the system is not in use. The card reader 15and telephone handset remain accessible to any potential user, so thatthe system can be initiated whenever desired. The chest compressionsubsystem and secure device box remain closed and locked withelectro-mechanical locks. Thus, the device is secured in the base untilneeded. When needed, the device can be removed from the base in theseveral ways described above. A trained first responder with an accesscard may insert the card into the card reader, and this will unlock theentire device from the base so that it can be carried to a heart attackvictim. An untrained bystander can initiate communications with theremote medical facility with the telephone handset, and uponinterrogation and confirmation of the bystanders need for the device,the device may be unlocked through the transmission of an appropriatesignal from the remote medical facility.

While the preferred embodiments of the devices and methods have beendescribed in reference to the environment in which they were developed,they are merely illustrative of the principles of the inventions. Otherembodiments and configurations may be devised without departing from thespirit of the inventions and the scope of the appended claims.

We claim:
 1. A medical treatment system for treatment of a patient,wherein said medical treatment system is intended to be used in anenvironment wherein the device may be removed from a secure storagedevice and deployed upon the patient by a first operator pending arrivalof a second operator, said medical treatment system comprising: aplurality of medical devices; means for controlling physical access tothe plurality of medical devices; means for controlling functionalenablement of a medical device included within the plurality of medicaldevices; means for identifying the first operator and permittingphysical access to a medical device by the first operator whileprohibiting functional enablement of the medical device to the firstoperator; means for identifying the second operator and permittingfunctional enablement of a medical device included within the pluralityof medical devices upon identification of the second operator; whereinthe means for controlling physical access is operable to permit physicalaccess to a medical device included within the plurality of medicaldevices depending upon the identity of the first operator; and the meansfor controlling functional enablement is operable to permit functionalenablement of a medical device included within the plurality of medicaldevices depending upon the identity of the second operator; wherein atleast one of the medical devices amongst the plurality of medicaldevices is capable of both diagnosis and treatment of a condition of thepatient, and the controller permits the first operator to operate the atleast one medical device in a diagnostic mode while prohibiting thefirst operator from operating the at least one medical device in atreatment mode.
 2. A medical treatment system for treatment of apatient, wherein said medical treatment system is intended to be used inan environment wherein the device may be removed from a secure storagedevice and deployed upon the patient by a first operator pending arrivalof a second operator, said medical treatment system comprising; aplurality of medical devices; means for controlling physical access tothe plurality of medical devices; means for controlling functionalenablement of a medical device included within the plurality of medicaldevices; means for identifying the first operator and permittingphysical access to a medical device by the first operator whileprohibiting functional enablement of the medical device to the firstoperator; means for identifying the second operator and permittingfunctional enablement of a medical device included within the pluralityof medical devices upon identification of the second operator; whereinthe means for controlling physical access is operable to permit physicalaccess to a medical device included within the plurality of medicaldevices depending upon the identity of the first operator; and the meansfor controlling functional enablement is operable to permit functionalenablement of a medical device included within the plurality of medicaldevices depending upon the identity of the second operator; wherein theat least one medical device is an automatic external defibrillator, andthe controller permits access to the automatic external defibrillator tothe first operator, thereby allowing the first operator to install theautomatic external defibrillator on the patient, but the systemprohibits the first operator from operating the automatic externaldefibrillator to apply defibrillating shock to the patient, and thesystem permits the second operator to operate the automatic externaldefibrillator to apply defibrillating shock to the patient.